FDA approves Babesia screening test for donated blood
Roche, a Swiss multinational pharmaceutical company, has received approval from the US Food and Drug Administration for a test to screen donated blood for Babesia.
If undetected, Babesia can be fatal in patients receiving blood transfusions from infected donors.
The newly approved test is called “cobas Babesia.”
From a Roche press release:
This is Roche’s first commercially available whole blood test to screen blood donations. It follows the May 2019 FDA-updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions.
Cobas Babesia detects parasites that live in red blood cells. This test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples.
The test can detect the four common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories.
In most cases, the Babesia parasite is transmitted to humans through the bite of an infected tick; however, the parasite can also be transmitted through blood transfusions or from mother to fetus during pregnancy.
The parasite infects and destroys red blood cells which can lead to anemia and related life-threatening complications, particularly in the elderly or otherwise immunocompromised patients.
In healthy people, the infection can be asymptomatic, or cause a range of mild flu-like symptoms.
PRESS RELEASE SOURCE: Roche